A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)

Phase 3CompletedNCT01918033

Organon and Co608 enrolled

Overview

This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine is superior to placebo after 2 weeks of treatment with regard to change from baseline in Total Nasal Symptom Score among Japanese participants with perennial allergic rhinitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

608

Conditions

Perennial Allergic Rhinitis

Interventions

Desloratadine 5 mgDRUG

Desloratadine 5 mg tablets

PlaceboDRUG

Matching placebo to desloratadine 5 mg tablets

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with perennial allergic rhinitis * Outpatient. Exclusion Criteria: * Lower respiratory tract infection or nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) * Coexisting infections or systemic mycosis for which there are no effective antibiotics * Asthma complication under treatment * Nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed * Vasomotor rhinitis or eosinophilic rhinitis * Nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug * History of hypersensitivity to antihistamines or study drug * Currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months * Has started specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent * Severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor * History of malignancy or clinically important hematological disorder * History of severe drug allergy (e.g., anaphylactoid reaction).

Outcomes

Primary Outcomes

Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2

The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.

Time frame: Baseline and Week 2

Number of Participants Experiencing an Adverse Event (AE)

An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized.

Time frame: Up to Week 4

Number of Participants Discontinuing Study Drug Due to an AE

An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.

Time frame: Up to Week 2

Secondary Outcomes

Data from ClinicalTrials.gov

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Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1

Time frame: Baseline and Day 3, Week 1

Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator

The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms.